Clearance Summary
KNIFE, OPHTHALMIC received FDA 510(k) clearance under submission number K871285, sponsored by Trueline Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-04-27.
- Submission: K871285
- Applicant / Sponsor: Trueline Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1987-04-27
Classification & Regulation
This clearance is catalogued under FDA product code HNN and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.